Clinical Research Directory

Inclusion Criteria: 1. Age 6-18 years old (including critical value); 2. Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria; 3. According to the 2018 ISN/RPS LN standards diagnosed with active Class III or IV LN, with or without a membranous component and the biopsy must be performed within 6 months prior to screening; 4. SLEDAI-2000 score ≥8 points; 5. Meeting the diagnosis of refractory lupus nephritis, 1. defined as treatment with two or more immunosuppressants (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolic acid analogues, leflunomide, and cyclosporine) for more than 6 months without inducing remission or relapse after remission, 2. accompanied by proteinuria without remission; 6. Positive expression of CD19 in peripheral blood B cells determined by flow cytometry; 7. Participants had good venous access, no contraindications for cell collection; 8. Participants and their guardians sign the informed consent, understand the study procedures and participate in the clinical study voluntarily; 9. The functions of important organs are basically normal: 1. Hematopoietic function (blood routine should meet): * Lymphocyte count ≥1×109/L, * White blood cell count ≥3×109/L, * Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to examination), * Hemoglobin ≥60g/L; 2. Liver function: * ALT≤3×ULN (except elevated ALT caused by inflammatory myopathy), * AST≤3×ULN (except for elevated AST caused by inflammatory myopathy), * TBIL≤1.5×ULN (except Gilbert syndrome, total bilirubin ≤3.0×ULN); 3. Renal function: eGFR ≥30 ml/(min.1.73m2) (Schwartz formula, except abnormal renal function by SLE); 4. Coagulation function: * International standardized ratio (INR) ≤1.5×ULN, * prothrombin time (PT) ≤1.5×ULN; 5. Heart function: hemodynamic stability; 10. Anti-nuclear antibody (ANA) ≥1:80; 11. Eastern Cancer Cooperation Group (ECOG) physical status score 0 to 2. Exclusion Criteria: 1. Received kidney transplant previously; 2. Serious drug allergy history or allergy; 3. Presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment; 4. Complicated with severe organ dysfunction of heart, liver, lung or coagulation dysfunction; 5. Complicated with congenital immunoglobulin deficiency; 6. Participants with infectious diseases: 1. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc Ab) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; 2. Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; 3. Human immunodeficiency virus (HIV) antibody positive; 4. Syphilis positive; 7. Diagnosed with malignant tumors in the last five years. 8. Suffer from severe central nervous system disease, mental illness and severe cognitive dysfunction; 9. Participated in other clinical trials within 3 months before enrollment; 10. Received CAR-T therapy previously; 11. Other situations that the researcher considers unsuitable for inclusion.